Kornimate/medical-research-clean huggingface dataset:
treatment-free remission accomplished with dasatinib in patients with cml

Conditions: Chronic Myeloid Leukemia

Summary: the purpose of this study is to find out how to increase the potential for achieving an "operational cure" from chronic myeloid leukemia. an "operational cure" is a state in which a person does not require further treatment, although there may be some remaining cancer cells. patients would normally remain on a tk inhibitor indefinitely within a standard of care setting for chronic myeloid leukemia. within this clinical trial, patients will discontinue their tk inhibitor prematurely. if any signs of progression are identified, dasatinib will be introduced. this research is being done because dasatinib has been shown to achieve a greater response in a much higher proportion of patients as compared to imatinib. dasatinib is approximately 300 times more potent than imatinib, and it is possible that a greater response can be achieved by dasatinib than by imatinib.

this is an open label, single arm phase ii trial that will examine how safe and effective it will be for patients with chronic myeloid leukemia (cml) to discontinued first line tyrosine kinase inhibitor (tki) therapy. the main goal of this study is to determine the potential role of dasatinib (the study drug) in helping patients with cml attain a sustained treatment free remission. during this study the safety and tolerability of dasatinib will be evaluated by means of drug related toxicity, adverse event reports, physical examinations and laboratory safety evaluations. the study period for an individual patient is expected to be approximately between 30-72 months. a total of 135 patients will be recruited from 10 canadian centres.

Eligibility criteria:
inclusion criteria: 1. diagnosis of cml 2. treatment of chronic phase cml treated for a minimum of three years exclusively with imatinib 3. levels of bcr-abl by rq-pcr with ≥ 4.5 log reduction from baseline 4. provide written informed consent 5. eastern cooperative oncology group (ecog) performance status ≤ 2 6. age \>18 years. 7. adequate organ liver and renal functions 8. normal serum levels (within normal limits) exclusion criteria: 1. prior treatment with a tki (except for imatinib, hydroxyurea, anagrelide or interferon) 2. taking any medications or substances known to affect cyp3a4. 3. concurrent medical condition which may increase the risk of toxicity 4. history of significant bleeding disorder unrelated to cancer 5. cardiac symptoms 6. clinically significant hypokalemia or hypomagnesemia that cannot be corrected prior to dasatinib administration
a clinical trial of a covid-19 vaccine named recombinant novel coronavirus vaccine (adenovirus type 5 vector)

Conditions: COVID-19

Summary: this study is a randomized, double-blind, placebo -controlled iib clinical trial, in order to evaluate the safety and immunogenicity of recombinant novel coronavirus vaccine (adenovirus type 5 vector) in people 6 years old and above and .

this is a phase iib clinical trial to evaluate safety and immuogenicity of ad5-ncov developed by cansino and beijing institute of biotechnology in health people aged 6 years old and above. the study will be double-blind, placebo-controlled trial with participants randomly allocated 2:1 to placebo and experimental vaccine . the immunization schedule is two doses intramuscular injections (deltoid).

Eligibility criteria:
inclusion criteria: * aged 18 to 55 years old in mid group; aged 6-17 years old in min group; aged 56 years and above in old group; aged in ebo group is not limited. * able to understand the content of informed consent and willing to sign the informed consent * able and willing to complete all the secluded study process during the whole 6 months study follow-up period. * negative in hiv diagnostic test. * negative in serum antibodies (igg and igm) screening of covid-19. * axillary temperature ≤37.0°c. * general good health as established by medical history and physical examination. exclusion criteria: * family history of seizure, epilepsy, brain or mental disease * subject allergic to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past. * woman who is pregnant, breast-feeding or positive in β-hcg (human chorionic gonadotropin) pregnancy test (urine) on day of enrollment, or become pregnant during the next 6 months * any acute fever disease or infections. * history of sars * major congenital defects or not well-controlled chronic illness, such as asthma, diabetes, or thyroid disease. * serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension without controllable drugs, etc. * hereditary angioneurotic edema or acquired angioneurotic edema urticaria in last one year * no spleen or functional spleen. * platelet disorder or other bleeding disorder may cause injection contraindication * faint at the sight of needles. * prior administration of immunodepressant or corticosteroids, antianaphylaxis treatment, cytotoxic treatment in last 6 months. * prior administration of blood products in last 4 months * prior administration of other research medicines in last 1 month * prior administration of attenuated vaccine in last 1 month * prior administration of inactivated vaccine in last 14 days * current anti-tuberculosis prophylaxis or therapy * according to the judgement of investigator,various medical, psychological, social or other conditions, those could affect the subjects to sign informed consent.

Keywords: covid-19 vaccine ad5 safety immunogencity sars-cov-2 adenovirus vector
safety and performance of ultra/ultra 3d cl with hifocus slimj electrode in adults with severe-to-profound hearing loss

Conditions: Cochlear Hearing Loss

Summary: this is a prospective study designed to evaluate the safety and performance of the hirestm ultra cl hifocustm slimj electrode and hirestm ultra 3d cl hifocustm slimj electrode (ultra x) under normal conditions of use as it is approved for this device. participants receive interventions as part of routine medical care.

this study is set up to document any adverse events and comparing pre- to post-implant benefit to subjects. any adverse events associated with the device will be documented via advanced bionics complaint handling system for the lifetime of the device. a within-subjects repeated-measures design will be employed. speech perception will be evaluated preoperatively with conventional amplification to determine candidacy and to establish baseline performance. efficacy parameters are speech perception data which will be collected according to clinical routine with a 6 month follow up period. subjects will be implanted unilaterally with the ultra x according to standard clinical care. the primary efficacy objective is to demonstrate that mean monosyllabic word recognition score with the ultra x used in combination with a sound processor programmed with the latest fitting software six months after activation is at least 20% better than the mean word score at baseline with conventional amplification in the same ear. the primary efficacy endpoint is reached six months after device activation.

Eligibility criteria:
inclusion criteria: * no previous experience with any auditory implant * 18 years of age or older * postlingual onset of severe hearing loss (≥ 4 years of age) * limited benefit from appropriately fitted hearing aids, defined as scoring 60% or less in freiburger monosyllabic word test * german language proficiency * willingness to participate in all scheduled procedures outlined in the protocol exclusion criteria: * cochlear malformation or obstruction that would preclude full insertion of electrode array. * presence of additional disabilities that would prevent or interfere with participation in the required study procedures * medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures * evidence of central auditory lesion or compromised auditory nerve * pregnancy at time of surgery.
efficacy and safety of pmk-s005 in the prevention of recurrent peptic ulcer in low-dose aspirin users

Conditions: Peptic Ulcer

Summary: the purpose of this study is to evaluate the efficacy and safety by comparing prevention of recurrent peptic ulcer in low-dose aspirin users between pmk-s005 and placebo.


Eligibility criteria:
inclusion criteria: * male or female over 19 years of age * accompanied by hypertension, diabetes, ischemic heart disease, arrhythmia, dyslipidemia patients who are required to continuous administration of low-dose aspirin(100mg) * patients who get modified lanza score (mls) 0 in screening period according to endoscopic findings * patients who have stomach or duodenal ulcer scar in screening period according to endoscopic findings. but, the cases that scars caused by other disorders or endoscopic treatment are excluded * patients who have no digestive symptoms(except for mild physconia, abdominal pain, diarrhea and vomit, nausea-vomiting) in screening period * signature of the written informed consent exclusion criteria: * within 4 weeks prior to screening period, patients who continuously take aspirin or nsaids * patient who has hypersensitivity to pmk-s005 and aspirin components or is banned to use them * patients who had a abdominal surgery that affect gastrointestinal motility (except appendectomy and hysterectomy), but, patients who had enterectomy is excluded regardless of the time period * patients who are judged by investigator that they have other upper gastroesophageal disease, active/healing-stage peptic ulcer, digestive malignant tumor or barrett's esophagus * patients with irritable bowel syndrome (ibs), inflammatory bowel disease (ibd), ulcerative colitis, crohn's disease, zolinger-ellison syndrome * history of esophagus, liver, pancreas, stomach, colorectal cancer or malignant tumors within 5 years * history of malabsorption within 3 months prior to screening period * patients who have been taken drug that affect the validity within 2 weeks before beginning of the clinical test * patient who is needed continuously to take antithrombotic agents , anti- coagulant , anti- choline agents, prostaglandins , mucosal protective agents , methotrexate, antidepressants , iron treat agents during clinical test. * patients with clinical meaningful laboratory test results * known alcohol and/or any other drug abuse or dependence * pregnant or lactating women * women planning to become pregnant * within 1 month, patients who have been taken other clinical test drug * patients who are judged by investigator that participation of the study is difficult

Keywords: prevention recurrent peptic ulcer
prognosis of elderly patients with acute poisoning.

Conditions: Acute Poisoning

Summary: acute poisoning is a major public health problem all over the world, it causes significant mortality and morbidity. it primarily involves younger populations, with less than 3% of the affected cases being in people aged 60 years or older in most studies. more than half of the intoxication events in the elderly over 65 years old were accidental.

the elderly are different from younger adults in many aspects. there are age related physiological changes. they have a higher incidence of comorbidities and use of many medications for chronic conditions, both of which make the elderly more susceptible to acute poisoning and its related consequences. although the elderly form a relatively small proportion of those admitted to hospital for acute self-poisoning, the poisoning in them is often more serious, complications are more frequent and a fatal outcome is more common. the presence of multiple physical, social, and psychiatric problems, with possible difficulties in the diagnosis of poisoning make the management of the elderly more complicated than that of younger poisoned patients. there are three main difficulties in diagnosing acute poisoning in the elderly. at first, it may not be easily obvious that the patient has taken an overdose. secondly, the presence of pre-existing diseases may obscure the clinical picture and finally, the drug may cause physical signs that similar to common problems of old age.

Eligibility criteria:
inclusion criteria: all patients more than 60 years will be included. exclusion criteria: younger than 60 years.
co(mbined therapy of malignant) s(alivary gland tu)m(ours with)i(mrt and) c(arbon ions): cosmic

Conditions: Malignancy; Salivary Glands; Tumor

Summary: the cosmic trial is a prospective, mono-centric, phase ii trial evaluating toxicity and efficacy in the combined treatment with intensity-modulated radiation therapy (imrt) and carbon ion (c12) boost. primary endpoint is mucositis ≥ ctc°3, secondary endpoints are local control, disease-free survival, and toxicity. planned accrual of the trial includes 54 patients with histologically proved (≥r1-resected, inoperable or pn+) salivary gland malignancies. treatment consists of 24 gye carbon ions (8 fractions) and 50 gy imrt (2.0 gy/ fraction).

local control in malignant salivary gland tumours is dose dependent. high local control rates in adenoid cystic carcinomas could be achieved by highly conformal radiotherapy techniques and particle (neutron/ carbon ion) therapy. considering high doses are needed to achieve local control, all malignant salivary gland tumours probably profit from the use of particle therapy, which in case of carbon ion treatment, has been shown to be accompanied by only mild side-effects. methods/ design: the cosmic trial is a prospective, mono-centric, phase ii trial evaluating toxicity in the combined treatment with intensity-modulated radiation therapy (imrt) and carbon ion (c12) boost in 54 patients with histologically proved (≥r1-resected, inoperable or pn+) salivary gland malignancies. patients receive 24 gye carbon ions (8 fractions) and imrt (2.0 gy/ fraction). study objectives: incidence of mucositis ≥ ctc°3 will be assessed as the primary endpoint of the trial, local control, disease-free survival, toxicity (incl. mucositis ctc °i-ii and late toxicity at 3 years post rt)

Eligibility criteria:
inclusion criteria: * histologically confirmed or surgically removed malignant tumour of the salivary glands (head and neck) * inoperable tumour * g2/3 * macroscopic or microscopic residual tumour (r2/ r1) or * ≥t3/t4 or * perineural invasion (pn+) * written informed consent * pts aged 18 - 80 years * effective contraception for pts in childbearing age (\<12 months post beginning of menopause) exclusion criteria: * prior radio- or chemotherapy for tumours of the head and neck * other previous malignancy within the past 5 years except prior, adequately treated basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix * significant neurological or psychiatric condition including dementia or seizures or other serious medical condition prohibiting the patient's participation in the trial by judgement of the investigators * legal incapacity or limited legal capacity * positive serum/ urine beta-hcg/ pregnancy * drug abuse

Keywords: cancer of the salivary glands radiation carbon ion therapy
a trial comparing nonacog beta pegol (n9-gp) and alprolix® in patients with haemophilia b

Conditions: Congenital Bleeding Disorder; Haemophilia B

Summary: this trial is conducted in europe and the united states of america. the aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (n9-gp) and alprolix® in patients with haemophilia b.


Eligibility criteria:
inclusion criteria: * male, aged 18-70 years (both inclusive) at the time of signing informed consent * patients with the diagnosis of congenital haemophilia b with factor ix activity below or equal to 2%, based on medical records * history of more than 150 exposures days to any factor ix containing products exclusion criteria: * known history of factor ix inhibitors * inhibitors to factor ix (above or equal to 0.6 bu) at screening measured by the nijmegen modified bethesda method * immunocompromised (cd4+ t cells below or equal to 200/μl) * known congenital or acquired coagulation disorders other than haemophilia b * body mass index above 35 kg/m\^²
cytokine gene polymorphisms in gastric diseases

Conditions: Gastric Ulcer; Duodenal Ulcer; Gastric Cancer

Summary: recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. we intended to clarify the association between polymorphisms of pro-inflammatory and anti-inflammatory cytokines, and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

h. pylori infection has close associations with the development of peptic ulcer diseases as well as gastric cancer, gastric adenoma, and gastric malt lymphoma. the association of the host genetics with the susceptibility to various gastroduodenal disorders has been intensively investigated in the pathogenesis of peptic ulcer and gastric cancer by h. pylori infection . in chronic active gastritis induced by h. pylori infection, activated neutrophils and mononuclear cells produce several pro-inflammatory and anti-inflammatory cytokines. in fact, levels of pro-inflammatory and anti-inflammatory cytokines are elevated in gastric mucosa infected with h. pylori. cytokine polymorphisms are associated with various inflammatory and autoimmune diseases. recently, cytokine polymorphisms are considered to play an important role in the pathogenesis of peptic ulcer and gastric cancer. however, the roles of the il-10 polymorphisms on the pathogenesis of h. pylori-related gastric cancer and peptic ulcer have not been fully elucidated.it is unclear whether pro-inflammatory and anti-inflammatory cytokines polymorphisms were associated with pathogenesis of peptic ulcer and gastric cancer in japan. then, we intended to clarify the association between polymorphisms of il-10 and the susceptibility to gastric cancer, gastric ulcer and duodenal ulcer in japan, and to detect the individuals who have higher risks for gastrointestinal disease development.

Eligibility criteria:
inclusion criteria: - exclusion criteria: * patinets without h. pylori
analysis of body mass index in central precocious puberty patients treated with leuprolide acetate

Conditions: Precocious Puberty, Central

Summary: analysis of body mass index in central precocious puberty patients treated with leuprolide acetate


Eligibility criteria:
inclusion criteria: 1. child diagnosed with cpp who has a peak-stimulated lutenizing hormone(lh) concentration over 5 iu/liter before initiation of therapy 2. chronological age(ca) at the appearance of pubertal changes less than 8 years in girls and less than 9 years in boys. 3. tanner stage ≥2 4. advanced bone age (bone age/chronological age \>1.1) 5. able to have the signed written informed consent provided by the patients' parents or legal guardians prior to any study-related procedures exclusion criteria: 1. patient with a peripheral precocious puberty: extrapituitary secretion of gonadotropins or gonadotropin-independent gonadal or adrenal sex steroids secretion 2. patient with a cerebral tumor requiring a neurosurgery or cerebral irradiation known chronic disease of underlying medical condition 3. currently on or planning growth hormone treatment 4. previous gonadotropin-releasing hormone agonist treatment 5. any patient who in opinion of the investigator should not participate in the study
the effect of intermittent oro-esophageal tube feeding on severe traumatic brain injury patients with tracheostomy

Conditions: Traumatic Brain Injury

Summary: this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding (n=50) or the control group with nasogastric tube feeding (n=48) for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

the safe and effective nutrition support for severe traumatic brain injury patients with tracheostomy continues to be a challenge. nasogastric tube feeding has been the mainstream choice in china but with the risk of complications. intermittent oro-esophageal tube feeding is an established modality of enteral nutrition support that can be used with routine treatment. this study reports the clinical outcomes of intermittent oro-esophageal tube feeding vs. nasogastric tube feeding, in patients receiving routine treatment. this was a multicenter randomized controlled study of 98 severe traumatic brain injury patients with tracheostomy. patients enrolled were divided randomly into the observation group with intermittent oro-esophageal tube feeding (n=50) or the control group with nasogastric tube feeding (n=48) for enteral nutrition support, respectively. nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, meeting the diagnosis of severe traumatic brain injury; * score of glasgow coma scale\<8; * presence of no contraindication for enteral nutrition; * with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications; * informed consent form was obtained from the patient\&#39;s family members, indicating their full understanding of the study and agreement to participate. exclusion criteria: * unable to cooperate in completing treatment and assessment due to personal reasons or other disorders; * complicated with other intracranial lesions, such as stroke; * with severe consciousness disorders caused by other diseases.
genomic profilation for therapeutic purposes in sarcomas and molecular tumor board (mtb): retrospective/prospective study in referral centers

Conditions: Sarcoma

Summary: multicenter noninterventional, translational study, retrospective/prospective designed in order to assess the aptitude to the use of genomic profiling methods for therapeutic purposes and evaluation by the institutional molecular tumor board (mtb) of sarcoma patients with metastatic/locally advanced disease that is inoperable with no viable therapeutic alternatives or with histotypes known to be resistant to available in-label medical treatments and without already therapeutically validated driver mutations.


Eligibility criteria:
inclusion criteria: * sarcoma patients of any age (inclusion of centers pediatric) * patients with any histotype of soft tissue sarcomas and bone * patients at any stage of the treatment pathway for disease that is localized or metastatic/inoperable * availability of follow-up data * written informed consent (prospective part/patients in follow-up)